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A Phase I/IIa Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AZD0022 as Monotherapy and in Combination With Anti-cancer Agents in Adult Participants With Tumours Harbouring a KRASG12D Mutation

NCT06599502 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2026-03-18

No results posted yet for this study

Summary

This is a first-in-human, modular, Phase I/IIa, open-label, multi-centre study to assess the safety, tolerability, PK, and preliminary efficacy of AZD0022 monotherapy in combination with other anti-cancer agents in participants with tumours harbouring a KRASG12D mutation.

Conditions

  • Advanced Solid Tumours
  • Non-Small Cell Lung Cancer (NSCLC)
  • Pancreatic Ductal Adenocarcinoma (PDAC)
  • Colorectal Cancer (CRC)

Interventions

DRUG

AZD0022

AZD0022 is an oral KRASG12D inhibitor that blocks KRASG12D function in patients with this type of mutation.

DRUG

Cetuximab

Cetuximab (Erbitux®) is a recombinant chimeric human/mouse Immunoglobulin G monoclonal antibody which binds to EGFR and competitively inhibits the binding of EGFR and other ligands

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-18
Primary Completion
2025-10-20
Completion
2026-01-29
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Japan
  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06599502 on ClinicalTrials.gov